Ziva Abraham, PhD
Ziva Abraham is the President and Founder of Microrite, Inc., a California based consulting firm providing consulting and training services to pharmaceuticals, biotechnology, medical devices and in vitro diagnostics in the areas of quality assurance, quality control, microbiology, and validation. Ziva has over 35 years of academic, research, clinical and industrial experience in microbiology, and quality assurance. Ziva has received her Master’s Degree in microbiology and has conducted research on developing microbial Insecticides using entomogenous bacteria and fungi. Her career also includes founding and managing clinical laboratories for Maccabi Medical in Israel.
She uses her extensive clinical microbiology experience to teach why assessing risk of microbial contamination should be in the forefront of any company that has products for human/veterinary use. Her experience in clinical laboratories has provided her with the framework to understand the effects of microbial contamination in products from a patient safety perspective.
Susan L. Ashley, PhD
Merck & Co., Inc.
Susan Ashley has a bachelor’s degree in Pharmacy and doctorate in Pharmaceutics. She has more than 25 years of experience in global drug development, manufacturing, and strategy. Susan has worked for Merck, Pfizer Animal Health (formerly SmithKline Beecham Animal Health), and Marion Merrell Dow. Her areas of expertise and experience include quality control testing and release; semi-solid and solid dosage form design, scale up, technology transfer, and full-scale process validation; regulatory CMC; project management; sterile supply support; single-use component design and support for large molecule and sterile manufacturing; process simulation for sterile products; and aseptic behavior and technique training. She currently leads the Aseptic Training Initiative within Merck and has been responsible for developing and delivering a standard aseptic training curriculum for the Global Merck Sterile Network.
Tiffany A. Baker, MBA
Tiffany Baker is a quality risk management and microbiology consultant with ValSource, LLC. She specializes in development and implementation of innovative approaches to quality risk management (QRM), QRM program design, facilitating risk assessments, creating a risk-focused culture, and developing risk-based approaches to support contamination control strategies. Tiff is an active member of the Parenteral Drug Association (PDA), a faculty member for PDA’s Training Research Institute, and an instructor for the PDA courses on quality risk management foundations as well as practical application of QRM tools. She is also co-lead for the PDA task force on Remote Audits and Inspections. Additionally, she was a member of the core team who co-authored the ISPE Baseline guide 5 - Commissioning and Qualification, incorporating QRM into the process. She has a BS in microbiology from the University of Rhode Island and an MBA from Providence College.
Azbil Telstar Technologies SL
Bachelor on Pharmacy from the University of Barcelona (1988), PDG (General Management Program, 2002) from IESE (Barcelona), and Industrial and Pharmacy Technology specialist (2001). Appointed as member of the Royal Catalan Academy of Pharmacy from 2016. More than 30 years of industry experience: 10 years at AlconCusi Laboratories as Manager of the factory for solid and liquid forms (3 years) and then promoted to Head of Quality Assurance and Technical Director. From 1998, he began his consultancy activity as MD of SVS, internationalizing the company and making it grow until its integration into the Telstar group, where he has been employed in different roles, always in local and outside markets. Currently working at Azbil Telstar as Global Consultancy Manager. Author of several technical articles and books & lecturer at many specialized courses worldwide, about sterile production, pharmaceutical utilities, plant design, quality assurance, inspections preparation and general production. He has also been a trainer on several occasions for the Spanish Medicine Agency.
Daniel Bice is an Assoicate Director for Quality Control Operations at Adaptimmune LLC, focusing on release of all drug products, validation of rapid microbiological methods (RMMs), and establishing risk-based environmental monitoring programs. Dan has 10 years of microbiology experience in the pharmaceutical industry. He has been an active PDA member since 2017. Dan earned his B.S. in Life Sciences from The Pennsylvania State University.
Renée S. Blosser, MS
Renée Blosser joined the FDA in 2004 and is currently a Master Microbiology Reviewer in the Division of Manufacturing Technologies, Office of New Animal Drug Evaluation at CVM. She has extensive experience in aseptic processing for finished drug products and review of media fill and sterility failure investigations. She also serves as a Quality Assessment Lead for review of pioneer and generic injectable drug products. Prior to joining the FDA, Renée worked in the field of antimicrobial drug development and surveillance of antimicrobial resistance.
Renée received a Bachelor of Science in Biology from Florida State University and a Master of Science in Microbiology from the University of South Florida.
Jay S. Bolden
Mr. Jay Bolden is an Associate Quality Advisor-Biologist in the Eli Lilly and Company Global Quality Laboratories. He is an internal endotoxin subject matter expert and leads a team with global QC oversight for developing, validating, transferring and troubleshooting endotoxin, microbiology, QPCR and ELISA methodologies. Jay holds a B.S. in Biology and an Environmental Studies certificate from Indiana University, and has over 21 years of industry experience in development, process and laboratory microbiology, and microbiology laboratory leadership.
Kenneth W. Boone
Merck & Co., Inc.
Ken Boone is a Director of Sterile & Microbiology Quality Assurance within the Global Compliance group at Merck. His current responsibilities include sterility assurance and aseptic processing for Merck sites globally that produce sterile and low bioburden products and to ensuring sites' compliance with current regulatory guidelines and expectations. Before Merck, Ken had a variety of global and site-based microbiology, aseptic processing, and sterility assurance responsibilities for Novartis, Mallinckrodt, Cardinal Health, and Pfizer. He has been a member of PDA since 2002 and is a founding member and former President-elect of the PDA Missouri Valley Chapter and currently President-elect of the PDA Southeast Chapter. Ken is a graduate of the University of Kansas.
Jette Christensen, MSc
Novo Nordisk A/S
Jette Christensen works at Novo Nordisk A/S where she has held several different positions. She currently serves as the Scientific Director of Biopharm Manufacturing Development. In this position she is responsible for setting cross functional directions within supporting process areas and for driving continuous improvements. In the past her main focus has been on the aseptic processing area and also on quality processes. Currently she is among others heading up a project about implementation of CCS for all Novo Nordisk facilities. She has more than 20 years’ experience within the pharmaceutical industry.
Jette has been active in PDA for several years. She has been member of several task forces preparing documents covering the aseptic area, been member of Science Advisory Board and currently she is Chair for the Board of Directors.
Tamara Garcia-armisen, PhD
Tamara Garcia-Armisen is a senior scientist currently in charge of the Sterility Assurance and contamination control strategy for aseptic manufacturing of viral vaccines bulk (Biologicals) at GSK. She holds a Master in Microbiology and Molecular biology and a PhD in Microbiology from the ULB (Free University of Brussels). Tamara has over 20 year of academic and industrial experience in Microbiology and Quality Assurance. Previous roles included microbiology and sterility assurance expert for QC and QA in plasma-derivate products manufacturing; Research Scientist in Sterility assurance for medical devices in charge of development and Validation of sterilization and disinfection strategies and Academic researcher authoring more than 20 papers in peer reviewed journals in Environmental Microbiology and water contamination topics. This experience across different fields, different products and lifecycle steps and different companies allow her to have a complete vision of the main challenges of the industry for the next years in the Contamination control and sterility assurance topics.
Miriam Guest is an Associate Principal Scientist, Microbiology at AstraZeneca, working in the New Modalities and Parenteral Development group; based at their Macclesfield site in the UK. Miriam has worked in Pharmaceutical Development for over 20 years, in both microbiology & formulation laboratories and GMP manufacturing environments; more recently supporting complex supply chains and designing robust control strategies, including the associated regulatory authoring & interactions.
She leads the AZ Global Microbiology Forum, bringing together a global network to drive standardisation and quality principals in Microbiology.
Miriam devised & leads AstraZeneca’s “21st Century Microbiology Strategy”, to innovate, industrialise and implement technology solutions to drive efficiencies and process robustness benefits within the AZ global network. Miriam has led many cross site improvement projects, one of which was awarded the AZ Global Operations Award for Performance in 2019.
She is an active committee member of the Pharmaceutical Microbiology Interest Group (Pharmig) and co-chairs the Cross Industry Consortium on Modernisation of Microbiology.
Cindy M. Heath
Cindy Heath is a Senior Research Scientist at Lilly with expertise in laboratory process automation. She began her career at Hologic, supporting the development and launch of a fully automated infectious disease test platform. She then moved to Dow, where she implemented a high-throughput automation platform for microarray and Next-Generation Sequencing, followed by an Application Scientist role at Beckman Coulter Life Science guiding automation of their nucleic acid extraction portfolio. In her current role, she continues her passion for advancing automated solutions for the Global Quality Laboratory organization. She holds a Bachelor of Science in Molecular Biology from the CSUSM.
Brooke K. Higgins, MS
Brooke K. Higgins is a Senior Policy Advisor for the Global Compliance Branch 3 within the Division of Drug Quality I, Office of Manufacturing Quality, Office of Compliance at FDA's Center for Drug Evaluation and Research. Ms. Higgins is responsible for evaluating domestic and international pharmaceutical inspection reports, reviewing responses from industry, preparing associated regulatory actions, and providing training to ORA and CDER personnel. She has also served as an expert witness on CGMP violations in federal court. Prior to joining CDER in 2014, Ms. Higgins spent 12 years with the Office of Regulatory Affairs, first as an Investigator and later as a Pre-Approval Manager, both for the Baltimore District. While working as the Pre-Approval Manager, she continued performing domestic and international drug manufacturing inspections, became a member of the Pharmaceutical Inspectorate, and was a Level II drug certification auditor. Ms. Higgins received a M.S. in Food Science, focusing on food microbiology, and a B.S. in Biology from Virginia Tech.
Dan A. Klein, MA
Dan Klein currently holds the position of Senior Technical Service Manager at STERIS Corporation and has extensive experience in the antimicrobials industry. This experience includes over 20 years as a R&D Manager of Microbiology and Clinical affairs as well as management of a contract testing laboratory. His technical expertise includes supporting multiple areas including pharmaceutical, healthcare and Department of Defense projects. He specializes in microbiology, regulatory affairs, disinfectant applications, experimental testing and design.
Stephen E. Langille, PhD
Dr. Stephen Langille is a Senior Microbiology Consultant at ValSource, Inc. He specializes in microbiological and particulate matter contamination control of drug, device, and biological products. He holds a B.S. degree in Biology from the University of Massachusetts and a Ph.D.in Microbiology from the University of Maryland. Prior to joining ValSource in 2019, he spent 19 years with the FDA as a Microbiology Reviewer, Branch Chief, and Director of the Division of Microbiology Assessment in the Center for Drug Evaluation and Research. He currently serves as a member of the United States Pharmacopoeia’s Visual Inspection Expert Panel.
Anna F. Lau, PhD, D(ABMM)
National Institutes of Health
Dr. Lau received her Ph.D. from the University of Sydney, Australia, where her research focused on the development of novel diagnostic platforms for invasive fungal diseases. She completed her CPEP Clinical Microbiology Fellowship training at the NIH and is board-certified through the American Board of Medical Microbiology. In 2013, she joined the Clinical Microbiology Service at the NIH Clinical Center where she co-directed the Bacteriology, Specimen Processing, Parasitology, and Molecular Epidemiology sections. In 2018, Dr. Lau was promoted to Chief of the newly created Sterility Testing Service to support the NIH-wide cGMP aseptic processing and manufacturing of cellular therapy and drug pharmaceuticals for NIH clinical protocols.
Dr. Lau's translational research has focused on the development of rapid diagnostic platforms using molecular-based techniques and mass spectrometry. In her current role, Dr. Lau champions the education of clinical and pharmaceutical colleagues for GMP testing within a hospital environment. Her current research involves advancing testing platforms used in the pharmaceutical setting whilst also meeting FDA requirements for quality and patient safety.
Joseph E. McCall, SM (NRCM)
Joe McCall, SM (NRCM) is the Director of Quality Assurance Technical Services at ADMA Biologics in Boca Raton, FL. He has over 25 years of experience as a professional microbiologist at such companies as Bausch & Lomb, Genzyme, DSM Pharmaceuticals, STERIS Life Sciences, and Mass Biologics. Joe has been an active industry member throughout his career, teaching courses at PDA TRI, the University of Tennessee HSC, and providing training at FDA CBER Division of Product Quality and Manufacturing. Joe has delivered training seminars in pharmaceutical microbiology for companies in Europe, Asia, South America, and across the US. He has been a proud member of PDA for nearly 20 years and is one of the few ASM Certified Specialists in Pharmaceutical and Medical Device Microbiology on the National Registry of Certified Microbiologists.
John W. Metcalfe, PhD
Dr. John Metcalfe holds a BA in biology from Merrimack College in Andover, MA, and a PhD in microbiology from the University of Rhode Island. John spent 14 years teaching college microbiology courses prior to beginning a career in CDER in 2003. At FDA, John is a Senior Pharmaceutical Quality Assessor (SPQA) where he performs a microbiological quality assessment of both sterile and non-sterile drug products. He is an FDA Liaison to the USP Expert Committee on Pharmacy Compounding and is a published author in the area of drug product microbiological quality.
Michael J. Miller, PhD
Microbiology Consultants, LLC
Dr. Michael J. Miller is an internationally recognized microbiologist and subject matter expert in pharmaceutical microbiology, contamination control and the validation of rapid microbiological methods. He is the President of Microbiology Consultants, LLC (http://microbiologyconsultants.com) and owner of http://rapidmicromethods.com, an educational website dedicated to the advancement of rapid microbiological methods.
For more than 30 years, he has held numerous R&D, manufacturing, quality, business development and executive leadership roles at Johnson & Johnson, Eli Lilly and Company and Bausch & Lomb. In his current role, Dr. Miller consults with multinational companies in the areas of microbiology, quality and regulatory affairs in support of rapid methods, sterile and non-sterile pharmaceutical manufacturing and contamination control.
Dr. Miller has authored more than 100 technical publications and presentations and currently serves on the editorial and scientific review boards for American Pharmaceutical Review, European Pharmaceutical Review and the PDA Journal. Dr, Miller is the chairperson for the current revision of PDA Technical Report #33: and has served as an advisor to the USP Microbiology Expert Committee in the area of rapid sterility testing.
Dr. Miller holds a Ph.D. in Microbiology and Biochemistry from Georgia State University (GSU), a B.A. in Anthropology and Sociology from Hobart College.
HORIBA Advanced Techno, Co., Ltd.
The GMP Committee for Aseptic Products is one of the technical committees of PDA Japan chapter. It is made up of ten groups, each with experts in their respective fields who are actively engaged in research and discussion. Study results of each group have been reported at annual microbiology symposium which the committee hosted and provided participants state-of-art and practical information. One of the groups, the Rapid Microbiological Method (RMM) Research Group consists of RMM users (pharmaceutical companies) and RMM system suppliers. By their collaboration, they provide application and implementation case studies from scientific, engineering, and regulatory point of view, and contribute to further improvements of quality and safety of pharmaceutical products by wide use of RMM in Japan. The speaker, Yoko Nakai represents the GMP Committee for Aseptic Products. She has been a project manager for RMM system development and applications at HORIBA Advanced Techno, Co., Ltd. since 2017. HORIBA has been a member of RMM implementation study team with Bayer Yakuhin, Ltd., and Azbil Corporation.